Randomized study evaluating optimal dose, efficacy, and safety of E7386 plus lenvatinib versus treatment of physician’s choice in advanced/recurrent endometrial carcinoma previously treated with platinum-based chemotherapy and immune checkpoint inhibitors

Authors: Eskander, Ramez N. ^{a, ⁎}, Lee, Jung-Yun ^b, Mirza, Mansoor Raza ^c, Lorusso, Domenica ^{d, e}, MacKay, Helen ^f, Ray-Coquard, Isabelle ^g, Oaknin, Ana ^h, Gonzalez-Martin, Antonio ⁱ, Hasegawa, Kosei ^j, Corr, Bradley R. ^k, Wu, Xiaohua ^l, Leary, Alexandra ^m, Hu, Tianle ⁿ, Dutta, Lea ^o, Okpara, Chinyere E. ^p, McKenzie, Jodi ^o, Makker, Vicky ^q

Source: In International Journal of Gynecological Cancer March 2025

Survival by Depth of Response and Efficacy by International Metastatic Renal Cell Carcinoma Database Consortium Subgroup with Lenvatinib Plus Pembrolizumab Versus Sunitinib in Advanced Renal Cell Carcinoma: Analysis of the Phase 3 Randomized CLEAR Study

Authors: Grünwald, Viktor, Powles, Thomas, Kopyltsov, Evgeny, Kozlov, Vadim, Alonso-Gordoa, Teresa, Eto, Masatoshi, Hutson, Thomas, Motzer, Robert, Winquist, Eric, Maroto, Pablo, Keam, Bhumsuk, Procopio, Giuseppe, Wong, Shirley, Melichar, Bohuslav, Rolland, Frederic, Oya, Mototsugu, Rodriguez-Lopez, Karla, Saito, Kenichi, McKenzie, Jodi, Porta, Camillo

Source: In European Urology Oncology August 2023 6(4):437-446

Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice

Authors: Lorusso, Domenica, Colombo, Nicoletta, Herraez, Antonio Casado, Santin, Alessandro D., Colomba, Emeline, Miller, David Scott, Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally E., Ray-Coquard, Isabelle Laure, Shapira-Frommer, Ronnie, Kim, Yong Man, McCormack, Mary, Massaad, Rachid, Nguyen, Allison Martin, Zhao, Qi, McKenzie, Jodi, Prabhu, Vimalanand S., Makker, Vicky

Source: In European Journal of Cancer June 2023 186:172-184

Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001

Authors: Marth, Christian ^{1, *}, Tarnawski, Rafal ², Tyulyandina, Alexandra ^{3, 4}, Pignata, Sandro ⁵, Gilbert, Lucy ⁶, Kaen, Diego ⁷, Rubio, M Jesús ⁸, Frentzas, Sophia ⁹, Beiner, Mario ¹⁰, Magallanes-Maciel, Manuel ¹¹, Farrelly, Laura ¹², Choi, Chel Hun ¹³, Berger, Regina ¹⁴, Lee, Christine ¹⁵, Vulsteke, Christof ¹⁶, Hasegawa, Kosei ¹⁷, Braicu, Elena Ioanna ¹⁸, Wu, Xiaohua ¹⁹, McKenzie, Jodi ²⁰, Lee, John J ²¹, Makker, Vicky ²²

Source: In International Journal of Gynecological Cancer January 2022 32(1):93-100

Randomized Study Evaluating Optimal Dose, Efficacy And Safety Of E7386 + Lenvatinib Versus Treatment Of Physicians’ Choice In Advanced/Recurrent Endometrial Carcinoma Previously Treated With Anti-PD-(L)1 Immunotherapy

Authors: Eskander, Ramez N. ¹, Lee, Jung-Yun ², Mirza, Mansoor ³, Lorusso, Domenica ⁴, Mackay, Helen ⁵, Ray-Coquard, Isabelle ⁶, Oaknin, Ana ⁷, Gonzalez-Martin, Antonio ⁸, Hasegawa, Kosei ⁹, Corr, Bradley ¹⁰, Wu, Xiaohua ¹¹, Leary, Alexandra ¹², Hu, Tianle ¹³, Dutta, Lea ¹⁴, Okpara, Chinyere ¹⁵, Mckenzie, Jodi ¹⁴, Makker, Vicky ¹⁶

Source: In International Journal of Gynecological Cancer February 2025 35(2) Supplement 1

Increased Tumor Glycolysis Characterizes Immune Resistance to Adoptive T Cell Therapy

Authors: Cascone, Tina, McKenzie, Jodi A., Mbofung, Rina M., Punt, Simone, Wang, Zhe, Xu, Chunyu, Williams, Leila J., Wang, Zhiqiang, Bristow, Christopher A., Carugo, Alessandro, Peoples, Michael D., Li, Lerong, Karpinets, Tatiana, Huang, Lu, Malu, Shruti, Creasy, Caitlin, Leahey, Sara E., Chen, Jiong, Chen, Yuan, Pelicano, Helen, Bernatchez, Chantale, Gopal, Y.N. Vashisht, Heffernan, Timothy P., Hu, Jianhua, Wang, Jing, Amaria, Rodabe N., Garraway, Levi A., Huang, Peng, Yang, Peiying, Wistuba, Ignacio I., Woodman, Scott E., Roszik, Jason, Davis, R. Eric, Davies, Michael A., Heymach, John V., Hwu, Patrick, Peng, Weiyi

Source: In Cell Metabolism 1 May 2018 27(5):977-987

Characterization of Responses to Lenvatinib plus Pembrolizumab in Patients with Advanced Renal Cell Carcinoma at the Final Prespecified Survival Analysis of the Phase 3 CLEAR Study

Authors: Motzer, Robert J., Choueiri, Toni K., Hutson, Thomas, Young Rha, Sun, Puente, Javier, Lalani, Aly-Khan A., Winquist, Eric, Eto, Masatoshi, Basappa, Naveen S., Tannir, Nizar M., Vaishampayan, Ulka, Bjarnason, Georg A., Oudard, Stéphane, Grünwald, Viktor, Burgents, Joseph, Xie, Ran, McKenzie, Jodi, Powles, Thomas

Source: In European Urology July 2024 86(1):4-9

Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms.

Authors: Grünwald, Viktor, Powles, Thomas, Masatoshi Eto, Kopyltsov, Evgeny, Sun Young Rha, Porta, Camillo, Motzer, Robert, Hutson, Thomas E., José Méndez-Vidal, María, Sung-Hoo Hong, Winquist, Eric, Goh, Jeffrey C., Maroto, Pablo, Buchler, Tomas, Toshio Takagi, Burgents, Joseph E., Perini, Rodolfo, Cixin He, Okpara, Chinyere E., McKenzie, Jodi

Source: Frontiers in Oncology; 2024, p1-10, 10p

Subject Terms: SUNITINIB, RENAL cell carcinoma, BONE metastasis, THERAPEUTICS, TREATMENT effectiveness, PROGRESSION-free survival

Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer.

Authors: Kan Yonemori, Keiichi Fujiwara, Kosei Hasegawa, Mayu Yunokawa, Kimio Ushijima, Shiro Suzuki, Ayumi Shikama, Shinichiro Minobe, Tomoka Usami, Jae-Weon Kim, Byoung-Gie Kim, Peng-Hui Wang, Ting-Chang Chang, Keiko Yamamoto, Shirong Han, McKenzie, Jodi, Orlowski, Robert J., Takuma Miura, Makker, Vicky, Yong Man Kim

Source: Journal of Gynecologic Oncology; Mar2024, Vol. 35 Issue 2, p1-13, 13p

Subject Terms: ENDOMETRIAL cancer, EAST Asians, PHYSICIANS, CANCER chemotherapy, ADVERSE health care events, HEREDITARY nonpolyposis colorectal cancer

Geographic Terms: EAST Asia

Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open-label CLEAR trial.

Authors: Grünwald, Viktor¹ (AUTHOR), Motzer, Robert J.² (AUTHOR), Haanen, John B. A. G.³ (AUTHOR), Schmidinger, Manuela⁴ (AUTHOR), Staehler, Michael D.⁵ (AUTHOR), Goh, Jeffrey C.⁶ (AUTHOR), Voog, Eric⁷ (AUTHOR), Climent, Miguel Ángel⁸ (AUTHOR), George, Saby⁹ (AUTHOR), Burgents, Joseph E.¹⁰ (AUTHOR), Xie, Ran¹¹ (AUTHOR), McKenzie, Jodi¹¹ (AUTHOR), Porta, Camillo¹² (AUTHOR)

Source: Journal of Clinical Oncology. 2024 Supplement 4, Vol. 42, p364-364. 140p.

Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab.

Authors: Colombo, Nicoletta, Lorusso, Domenica, Monk, Bradley J, Slomovitz, Brian, Hasegawa, Kosei, Nogueira-Rodrigues, Angélica, Zale, Melissa, Okpara, Chinyere E, Barresi, Gianmaria, McKenzie, Jodi, Makker, Vicky

Source: Oncologist; Jan2024, Vol. 29 Issue 1, p25-35, 11p

Subject Terms: PREVENTION of drug side effects, THERAPEUTIC use of monoclonal antibodies, HYPERTENSION, MUSCULOSKELETAL system diseases, STRATEGIC planning, INTRAVENOUS therapy, HYPOTHYROIDISM, DIARRHEA, CANCER chemotherapy, ANTINEOPLASTIC agents, MONOCLONAL antibodies, PROTEIN-tyrosine kinase inhibitors, PHARMACEUTICAL arithmetic, ENDOMETRIAL tumors, DESCRIPTIVE statistics, WEIGHT loss, DRUG prescribing, RESEARCH funding, DRUG side effects, TERMINATION of treatment, FATIGUE (Physiology), PHYSICIAN practice patterns, PATIENT education

Efficacy and safety of lenvatinib plus pembrolizumab vs sunitinib in the East Asian subset of patients with advanced renal cell carcinoma from the CLEAR trial.

Authors: Rha, Sun Young, Choueiri, Toni K., Matveev, Vsevolod B., Alyasova, Anna, Hong, Sung‐Hoo, Gordoa, Teresa Alonso, Gurney, Howard, Bjarnason, Georg A., Buchler, Tomas, Pedrazzoli, Paolo, Takagi, Toshio, Park, Se Hoon, Lee, Jae Lyun, Perini, Rodolfo F., He, Cixin S., McKenzie, Jodi A., Eto, Masatoshi

Source: International Journal of Cancer; Sep2023, Vol. 153 Issue 6, p1241-1250, 10p

Subject Terms: SUNITINIB, HAND-foot syndrome, RENAL cell carcinoma, PEMBROLIZUMAB, PROTEIN-tyrosine kinase inhibitors, PLATELET count, PATIENT safety

Geographic Terms: EAST Asia, SOUTH Korea

Lenvatinib plus pembrolizumab versus chemotherapy as first-line therapy for advanced or recurrent endometrial cancer: Primary results of the phase III ENGOT-En9/LEAP-001 study

Authors: Marth, Christian ^a, Moore, Richard ^b, Bidzinski, Mariusz ^c, Pignata, Sandro ^d, Ayhan, Ali ^e, Rubio, M. Jesús ^f, Beiner, Mario ^g, Hall, Marcia ^h, Vulsteke, Christof ⁱ, Braicu, Elena Ioana ^{j, s}, Sonoda, Kenzo ^k, Wu, Xiaohua ^l, Frentzas, Sophia ^m, Mattar, André ⁿ, McKenzie, Jodi ^o, Yao, Lili ^p, Khemka, Vivek ^p, Orlowski, Robert ^p, Gilbert, Lucy ^q, Makker, Vicky ^r

Source: In Gynecologic Oncology November 2024 190 Supplement 1:S63-S64

Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms.

Authors: Grünwald, Viktor, Powles, Thomas, Masatoshi Eto, Kopyltsov, Evgeny, Sun Young Rha, Porta, Camillo, Motzer, Robert, Hutson, Thomas E., José Méndez-Vidal, María, Sung-Hoo Hong, Winquist, Eric, Goh, Jeffrey C., Maroto, Pablo, Buchler, Tomas, Toshio Takagi, Burgents, Joseph E., Perini, Rodolfo, Cixin He, Okpara, Chinyere E., McKenzie, Jodi

Source: Frontiers in Oncology; 2023, p01-10, 10p

Subject Terms: SUNITINIB, BONE metastasis, THERAPEUTICS, TREATMENT effectiveness, PROGRESSION-free survival

Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775.

Authors: Makker, Vicky¹ (AUTHOR) makkerv@mskcc.org, Colombo, Nicoletta² (AUTHOR), Herráez, Antonio Casado³ (AUTHOR), Monk, Bradley J.⁴ (AUTHOR), Mackay, Helen⁵ (AUTHOR), Santin, Alessandro D.⁶ (AUTHOR), Miller, David S.⁷ (AUTHOR), Moore, Richard G.⁸ (AUTHOR), Baron-Hay, Sally⁹ (AUTHOR), Ray-Coquard, Isabelle¹⁰ (AUTHOR), Ushijima, Kimio¹¹ (AUTHOR), Yonemori, Kan¹² (AUTHOR), Kim, Yong Man¹³ (AUTHOR), Guerra Alia, Eva M.¹⁴ (AUTHOR), Sanli, Ulus A.¹⁵ (AUTHOR), Bird, Steven¹⁶ (AUTHOR), Orlowski, Robert¹⁶ (AUTHOR), McKenzie, Jodi¹⁷ (AUTHOR), Okpara, Chinyere¹⁸ (AUTHOR), Barresi, Gianmaria¹⁹ (AUTHOR)

Source: Journal of Clinical Oncology. 6/1/2023, Vol. 41 Issue 16, p2904-2910. 7p.

Characterization of tumor response with lenvatinib plus pembrolizumab in study 309/KEYNOTE-775 (177)

Authors: Makker, Vicky, Lorusso, Domenica, Moore, Richard, Miller, David, Mackay, Helen, Santin, Alessandro, Ushijima, Kimio, Kim, Yong Man, Sanli, Ulus, Yonemori, Kan, Xie, Ran, Barresi, Gianmaria, McKenzie, Jodi, Colombo, Nicoletta

Source: In Gynecologic Oncology September 2023 176 Supplement 1:S68-S69

Corrigendum: Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms.

Authors: Grünwald, Viktor, Powles, Thomas, Masatoshi Eto, Kopyltsov, Evgeny, Sun Young Rha, Porta, Camillo, Motzer, Robert, Hutson, Thomas E., Méndez-Vidal, María José, Sung-Hoo Hong, Winquist, Eric, Goh, Jeffrey C., Maroto, Pablo, Buchler, Tomas, Takagi, Toshio, Burgents, Joseph E., Perini, Rodolfo, Cixin He, Okpara, Chinyere E., McKenzie, Jodi

Source: Frontiers in Oncology; 2024, p1-2, 2p

Subject Terms: RENAL cell carcinoma, SUNITINIB, MEDICAL sciences

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Aurora kinase inhibition sensitizes melanoma cells to T-cell-mediated cytotoxicity.

Authors: Punt, Simone, Malu, Shruti, McKenzie, Jodi A., Manrique, Soraya Zorro, Doorduijn, Elien M., Mbofung, Rina M., Williams, Leila, Silverman, Deborah A., Ashkin, Emily L., Dominguez, Ana Lucía, Wang, Zhe, Chen, Jie Qing, Maiti, Sourindra N., Tieu, Trang N., Liu, Chengwen, Xu, Chunyu, Forget, Marie-Andrée, Haymaker, Cara, Khalili, Jahan S., Satani, Nikunj

Source: Cancer Immunology, Immunotherapy; Apr2021, Vol. 70 Issue 4, p1101-1113, 13p

Subject Terms: AURORA kinases, CELLULAR aging, MELANOMA, PROTEIN kinases, IPILIMUMAB, TUMOR microenvironment